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Assessing Cardiovascular Risk: Guideline Synthesis

Strength of Evidence and Recommendation Grading System

ACCF/AHA (2010)
Applying Classification of Recommendations and Level of Evidence
Size of Treatment Effect
 CLASS I
Benefit >>> Risk
Procedure/treatment SHOULD be performed/administered
 CLASS II a
Benefit >> Risk Additional studies with focused objectives needed
IT IS REASONABLE to perform procedure/administer treatment
 CLASS II b
Benefit ≥ Risk
Additional studies with broad objectives needed; additional registry data
would be helpful Procedure/treatment MAY BE CONSIDERED
 CLASS III No Benefit
Procedure/test: Not helpful
Treatment: No proven benefit
 CLASS III Harm
Procedure/test: Excess cost without benefit or harmful
Treatment: Harmful to patients
Estimate of Certainty (Precision) of Treatment Effect
LEVEL A
Multiple populations evaluated*
Data derived from multiple randomized clinical trials or meta-analyses
Class I
 Recommendation that procedure or treatment is useful/effective
 Sufficient evidence from multiple randomized trials or meta-analyses
Class II a
 Recommendation in favor of treatment or procedure being
useful/effective
  Some conflicting evidence from multiple randomized trials or meta-
analyses
Class II b
 Recommendation's usefulness/efficacy less well established
 Greater conflicting evidence from multiple randomized trials or meta-
analyses
Class III
 Recommendation that procedure or treatment is not useful/effective and
may be harmful
 Sufficient evidence from multiple randomized trials or meta-analyses
LEVEL B
Limited populations evaluated*
Data derived from a single randomized clinical trials or nonrandomized studies
Class I
 Recommendation that procedure or treatment is useful/effective
 Evidence from single randomized trial or nonrandomized studies
Class II a
 Recommendation in favor of treatment or procedure being
useful/effective
 Some conflicting evidence from single randomized trial or
nonrandomized studies
Class II b
 Recommendation's usefulness/efficacy less well established
 Greater conflicting evidence from single randomized trial or
nonrandomized studies
Class III
 Recommendation that procedure or treatment is not useful/effective and
may be harmful
 Evidence from single randomized trial or nonrandomized studies
LEVEL C
Very limited populations evaluated*
Only consensus opinion of experts, case studies or standard of care
Class I
 Recommendation that procedure or treatment is useful/effective
 Only expert opinion, case studies, or standard-of-care
Class II a
 Recommendation in favor of treatment or procedure being
useful/effective
 Only diverging expert opinion, case studies, or standard-of-care
Class II b
 Recommendation's usefulness/efficacy less well established
  Only diverging expert opinion, case studies, or standard-of-care
Class III
 Recommendation that procedure or treatment is not useful/effective and
may be harmful
 Only expert opinion, case studies, or standard-of-care
*Data available from clinical trials or registries about the usefulness/efficacy in
different subpopulations, such as gender, age, history of diabetes, history of
prior myocardial infarction, history of heart failure, and prior aspirin use. A
recommendation with Level of Evidence B or C does not imply that the
recommendation is weak. Many important clinical questions addressed in the
guidelines do not lend themselves to clinical trials. Even though randomized
trials are not available, there may be a very clear clinical consensus that a
particular test or therapy is useful or effective.
NACB (2009)
Weight of Evidence
A. Data derived from multiple randomized clinical trials that involved large
numbers of patients
B. Data derived from a limited number of randomized trials that involved
small numbers of patients or from careful analyses of nonrandomized
studies or observational registries
C. Expert consensus was the primary basis for the recommendation
Modified American College of Cardiology/American Heart Association
Classifications: Summary of Indications
1. Conditions for which there is evidence and/or general agreement that a
given procedure or treatment is useful and effective
2. Conditions for which there is conflicting evidence and/or a divergence of
opinion about the usefulness/efficacy of a procedure or treatment
a. Weight of evidence/opinion is in favor of usefulness/efficacy
b. Usefulness/efficacy is less well established by evidence/opinion
3. Conditions for which there is evidence and/or general agreement that
the procedure/treatment is not useful/effective and in some cases may
be harmful
USPSTF (2009)
What the USPSTF Grades Mean and Suggestions for Practice
GRADE A
Grade Definition: The USPSTF recommends the service. There is high
certainty that the net benefit is substantial.
Suggestions for Practice: Offer or provide this service.
GRADE B
Grade Definition: The USPSTF recommends the service. There is high
certainty that the net benefit is moderate or there is moderate certainty that
the net benefit is moderate to substantial.
Suggestions for Practice: Offer or provide this service.
GRADE C
Grade Definition: The USPSTF recommends against routinely providing the
service. There may be considerations that support providing the service in an
individual patient. There is moderate or high certainty that the net benefit is
small.
Suggestions for Practice: Offer or provide this service only if other
considerations support offering or providing the service in an individual
patient.
GRADE D
Grade Definition: The USPSTF recommends against the service. There is
moderate or high certainty that the service has no net benefit or that the
harms outweigh the benefits.
Suggestions for Practice: Discourage the use of this service.
I STATEMENT
Grade Definition: The USPSTF concludes that the current evidence is
insufficient to assess the balance of benefits and harms of the service.
Evidence is lacking, of poor quality, or conflicting, and the balance of benefits
and harms cannot be determined.
Suggestions for Practice: Read "Clinical Considerations" section of USPSTF
Recommendation Statement (see "Major Recommendations" field). If this
service is offered, patients should understand the uncertainty about the
balance of benefits and harms.
USPSTF Levels of Certainty Regarding Net Benefit
Definition: The U.S. Preventive Services Task Force defines certainty as
"likelihood that the USPSTF assessment of the net benefit of a preventive
service is correct." The net benefit is defined as benefit minus harm of the
preventive service as implemented in a general, primary care population. The
USPSTF assigns a certainty level based on the nature of the overall evidence
available to assess the net benefit of a preventive service.
Level of Certainty: High
Description: The available evidence usually includes consistent results from
well-designed, well-conducted studies in representative primary care
populations. These studies assess the effects of the preventive service on
health outcomes. This conclusion is therefore unlikely to be strongly affected
by the results of future studies.
Level of Certainty: Moderate
 Description: The available evidence is sufficient to determine the effects of the
preventive service on health outcomes, but confidence in the estimate is
constrained by factors such as:
 The number, size, or quality of individual studies
 Inconsistency of findings across individual studies
 Limited generalizability of findings to routine primary care practice
 Lack of coherence in the chain of evidence
As more information becomes available, the magnitude or direction of the
observed effect could change, and this change may be large enough to alter
the conclusion.
Level of Certainty: Low
Description: The available evidence is insufficient to assess effects on health
outcomes. Evidence is insufficient because of:
 The limited number or size of studies
 Important flaws in study design or methods
 Inconsistency of findings across individual studies
 Gaps in the chain of evidence
 Findings not generalizable to routine primary care practice
 A lack of information on important health outcomes.
More information may allow an estimation of effects on health outcomes.

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AHRQ © 2012 Agency for Healthcare Research and Quality (AHRQ)

Cite this: Assessing Cardiovascular Risk: Guideline
Synthesis - Medscape - Mar 01, 2012.

 Guidelines Being Compared

 Areas of Agreement and Difference
 Comparison of Recommendations: Lipoprotein and Apolipoprotein
Assessments
 Comparison of Recommendations: Inflammation Markers (CRP, Fibrinogen,
White Blood Cell Count, Lp-PLA2)
 Comparison of Recommendations: Homocysteine Level
 Comparison of Recommendations: IMT, ABI, and Calcium Scoring Methods
 Comparison of Recommendations: Natriuretic Peptides
 Comparison of Recommendations: Metabolic and Renal Factors
 Strength of Evidence and Recommendation Grading System
 Methodology
 Source(s) of Funding
 Benefits and Harms
 Status

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